Back to results

Cannabidiol for the Treatment of Severe (Grades III/IV) Acute Graft-versus-host Disease

Primary Purpose

Acute-graft-versus-host Disease

Status

Unknown status

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Cannabidiol

Methylprednisolone

Calcineurin inhibitor

About this trial

This is an interventional treatment trial for Acute-graft-versus-host Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients 18 years or older
After allogeneic transplantation
Grade III or IV acute GVHD
No psychiatric contra-indication
Informed consent

Exclusion Criteria:

History of psychosis
Asthma
Known allergy to cannabis constituents

Sites / Locations

Davidof Cancer Center, Beilinson hospital, Rabin medical center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cannabidiol

Arm Description

Outcomes

Primary Outcome Measures

Proportion of patients with complete remission of acute GVHD

Secondary Outcome Measures

Proportion of patients with partial remission of acute GVHD

Proportion of patients with chronic GVHD

Proportion of patients able to discontinue immunosuppression

Transplant related mortality

Full Information

NCT ID

NCT02392780

First Posted

March 9, 2015

Last Updated

March 18, 2015

Sponsor

moshe yeshurun

1. Study Identification

Unique Protocol Identification Number

NCT02392780

Brief Title

Cannabidiol for the Treatment of Severe (Grades III/IV) Acute Graft-versus-host Disease

Official Title

Cannabidiol for the Treatment of Severe (Grades III/IV) Acute Graft-versus-host Disease

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Unknown status

Study Start Date

April 2015 (undefined)

Primary Completion Date

April 2018 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

moshe yeshurun

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Graft-versus-host-disease (GVHD) is a major obstacle to successful allogeneic hematopoietic cell transplantation (alloHCT). Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa possesses potent anti-inflammatory and immunosuppressive properties. In a recent phase 2 study, CBD has been shown to be safe and reduced significantly the incidence of acute GVHD compared to control patients with a hazard ratio of 0.3. Based on these results the investigators propose a phase 2 study to explore the efficacy of oral CBD in the treatment of severe (grades III/IV) acute GVHD, a pathology with a dismal prognosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute-graft-versus-host Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cannabidiol

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Cannabidiol

Intervention Description

Oral cannabidiol at a dose of 150 mg BID up to 90 days.

Intervention Type

Drug

Intervention Name(s)

Methylprednisolone

Intervention Description

IV methylprednisolone 2 mg/kg/day

Intervention Type

Drug

Intervention Name(s)

Calcineurin inhibitor

Intervention Description

cyclosporine with dose adjusted based on drug trough levels (200-400 ng/ml) or tacrolimus with dose adjusted on drug trough levels (5-15 ng/ml)

Primary Outcome Measure Information:

Title

Proportion of patients with complete remission of acute GVHD

Time Frame

90 days

Secondary Outcome Measure Information:

Title

Proportion of patients with partial remission of acute GVHD

Time Frame

90 days

Title

Proportion of patients with chronic GVHD

Time Frame

12 months

Title

Proportion of patients able to discontinue immunosuppression

Time Frame

12 months

Title

Transplant related mortality

Time Frame

12 months

Other Pre-specified Outcome Measures:

Title

Subpopulations of peripheral blood cells and cytokine levels

Description

T4, T8, Foxp3 T regulatory cells, TNFα, INFγ, IL-1β, IL-6, IL-17, IL-4, IL-5, IL-10 and IL-13

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients 18 years or older After allogeneic transplantation Grade III or IV acute GVHD No psychiatric contra-indication Informed consent Exclusion Criteria: History of psychosis Asthma Known allergy to cannabis constituents

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Moshe Yeshurun, MD

Phone

972-50-4065543

moshey@clalit.org.il

First Name & Middle Initial & Last Name or Official Title & Degree

Liat Shargian, MD

Phone

972-54-2394930

LIATSHR@clalit.org.il

Facility Information:

Facility Name

Davidof Cancer Center, Beilinson hospital, Rabin medical center

City

Petach Tikva

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Moshe Yeshurun, MD

Phone

972-50-4065543

moshey@clalit.org.il

First Name & Middle Initial & Last Name & Degree

Liat Shargian, MD

Phone

972-54-2394930

LIATSHR@clalit.org.il

12. IPD Sharing Statement

Learn more about this trial

Cannabidiol for the Treatment of Severe (Grades III/IV) Acute Graft-versus-host Disease

We'll reach out to this number within 24 hrs